About FDA Scientific Advisory Committee Meetings
FDA Scientific Advisory Committee (SAC) Meetings are public meetings that are convened by the US Food and Drug Administration to hear expert opinions from a specific field of research (i.e. cardiology), public opinion (patient groups and clinical trial participants) and physicians’ experience.
12 Key Facts About FDA Scientific Advisory Committees
- FDA Advisory committees are often referred to as FDA AdComms.
- FDA decides whether to bring a matter to an advisory committee. Some of the factors FDA considers when making the decision are:
- Is the matter at issue of such significant public interest that it would be highly beneficial to obtain the advice of an advisory committee as part of the agency’s regulatory decision-making process?
- Is the matter at issue so controversial that it would be highly beneficial to obtain the advice of an advisory committee as part of the agency’s regulatory decision-making process?
- Is there a special type of expertise that an advisory committee could provide that is needed for the agency to fully consider a matter?
- There are 33 advisory committees.
- Most committees align with therapeutic areas.
- Members sometimes vote about whether they believe a medical product has an acceptable risk to benefit profile for marketing approval in the US. At these meetings a drug sponsor presents general safety and efficacy data in the form of a briefing package submitted to the agency prior to the meeting and in the form of slides on the day of the meeting to support questions asked by the expert panel. The FDA typically posts background material online on the 2 business day before the meeting.
- Sometimes advisory committees vote about safety issues and related actions to advise the FDA to take.
- One committee is devoted to medical devices, but this committee has numerous separate panels.
- There are separate committees for vaccines and blood products, for drug safety and risk management and for nonprescription drugs.
- The committees meet requirements set forth in the Federal Advisory Committee Act of 1972.
- The FDA is not required to follow the advice of the committee, however they usually do (roughly 85-90% of the time).
- Many of these meetings are webcast.
- FDA tracks the performance quarterly through the FDA-TRACK program